Post-Approval Studies (PAS)

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

GEM21S (Formulated rhPDGF-BB) 0.5 mL in a 1 mL syringe on Long Term Stability at 2¢ªC - 8¢ªC (horizontal) will undergo stability testing.

Sample Size

Horizontal testing will be performed on at least one production lot annually, and a sample of three production lots will be tested out to 48 months for informational purposes (the current shelf life for the syringe is 42 months).